Results 1 to 10 of about 1,741 (131)

Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework

Pharmaceutics, 2021
Advanced therapy medicinal products (ATMPs) are a group of innovative and complex biological products for human use that comprises somatic cell therapy medicinal products, tissue engineered products, gene therapy medicinal products, and the so-called ...
Marina López-Paniagua, Ana de la Mata, Sara Galindo, Francisco Blázquez, Margarita Calonge, Teresa Nieto-Miguel   +5 more
doaj   +3 more sources

Bringing Advanced Therapy Medicinal Products (ATMPs) for Parkinson’s Disease to the Clinic: The Investigator’s Perspective [PDF]

Journal of Parkinson’s Disease, 2021
There is much excitement around the use of advanced therapy medicinal products (ATMPs), including cell and gene treatments, in Parkinson’s disease (PD). However, taking an ATMP to clinical trials in patients with PD is complex.
Roger A. Barker, Emma V. Cutting, Danielle M. Daft   +2 more
doaj   +2 more sources

Advanced therapy medicinal products in China: Regulation and development

MedComm, 2023
Advanced therapy medicinal products (ATMPs) have shown dramatic efficacy in addressing serious diseases over the past decade. With the acceleration and deepening of China's drug regulatory reforms, the country sees a continuous introduction of policies ...
Jiaqi Lu, Longchang Xu, Wei Wei, Wu He
doaj   +2 more sources

A roadmap for supporting the development of advanced therapy medicinal products in a European framework [PDF]

The Lancet Regional Health. Europe
Summary: Advanced therapy medicinal products (ATMPs) represent a paradigm shift in medicine; however, their implementation in European health systems is often hampered by EU regulations.
Johan Van Eldere, Alessandro Aiuti, Silvia Martin Lluesma, Bjarne Kuno Møller, Britt Elmedal Laursen, Celeste Lebbe, Alejandro Piris, Javier Carmona, Gady Goldsobel, Ulrich Kintscher, Peter Vandenberghe, Isabelle Huys, Bart Geers, Reuben Benjamin, Victoria Potter, Chiara Bonini, Fabio Ciceri, Gianvito Martino, Reno Debets, Hugo P.H.M. van der Kuy, Stephan Mielke, Pontus Blomberg, Ewa Ellis, Antonia M.S. Müller, Nina Worel, Annette Künkele   +25 more
doaj   +2 more sources

The polymeric nanovectors landscape for cancer immunotherapies towards advanced therapy medicinal products (ATMPs) [PDF]

Acta Pharmaceutica Sinica B
Despite major advances in oncology, cancer remains one of the leading causes of mortality worldwide, underscoring the need for more effective and personalized therapeutic solutions.
Ilaria Elena Palamà, Alessandra Invidia, Claudia De Stradis, Gabriella Leccese, Clara Baldari, Barbara Cortese, Clara Guido, Andrea Giglio, Concetta Quintarelli, Biagio De Angelis, Gabriele Maiorano, Franco Locatelli, Giuseppe Gigli   +12 more
doaj   +2 more sources

Defining core competencies for advanced therapy medicinal products translation [PDF]

Frontiers in Digital Health
BackgroundTranslating Advanced Therapy Medicinal Products (ATMPs) from research to clinical application requires a specialized set of priority topic areas that is not yet systematically defined.MethodsWe employed a multi-phase approach combining a ...
Elena Guillen, Ana Hidalgo-Simon, Ana Hidalgo-Simon   +2 more
doaj   +2 more sources

Cellularized Skin Substitute Bioengineering for Regenerative Medicine: Cell Sources, Culture Strategies, and Transition Toward Defined, Xeno-Free Culture Systems. [PDF]

Adv Healthc Mater
Advances in cell sources, bioengineering, and manufacturing are reshaping the design of skin substitutes. This review highlights emerging strategies driving skin tissue engineering and discusses their potential to enable safer, reproducible, and clinically accessible skin substitutes for regenerative medicine.
Lemaître G, Trouillas M, Vinasco-Sandoval T, Giordano C, Lellouch AG, Rachidi W, Lataillade JJ, Fortunel NO.   +7 more
europepmc   +2 more sources

The complex price setting and reimbursement of non-industrial advanced therapy medicinal products [PDF]

Health Economics Review
Background Advanced Therapy Medicinal Products (ATMPs) developed under the Hospital Exemption (HE) offer innovative treatments for patients with unmet medical needs, but their pricing and reimbursement (P&R) remain fragmented and poorly understood.
Zuzana Špacírová, Juan Carlos Rejon-Parrilla, Jaime Espín   +2 more
doaj   +2 more sources

Advanced Therapy Medicinal Products for Eye Diseases: Goals and Challenges

Pharmaceutics, 2021
Advanced therapy medicinal products (ATMPs) are a novel class of medicines with enormous potential to improve treatments for a wide range of diseases, including those affecting eye structures [...]
Yolanda Diebold, Laura García-Posadas
doaj   +1 more source

Surgery Versus ATMPs: An Example From Ophthalmology

Frontiers in Bioengineering and Biotechnology, 2020
Advanced therapy medicinal products (ATMPs) are the new frontier of medicine. Advanced therapy medicinal products are set out to satisfy unmet medical needs and provide new innovative, cutting-edge therapies for serious or life-threatening diseases, thus
Federica M. Magrelli, Alessia Merra, Graziella Pellegrini, Graziella Pellegrini   +3 more
doaj   +1 more source